Watch the 2025 ICH Guideline Training Videos

| ICH Guideline Videos by year |

Table of ICH Guideline Training Videos for FY 2025, categorized into ICH, Quality, and Multidisciplinary programs, with speaker information, video links in Korean and English, and downloadable materials
ICH Programs Speakers Video Materials
KOR ENG Files
ICH
ICH ICH Cooperation activity and implementation status of ICH guidelines in Korea Heesung Kim
(NIFDS, MFDS)
Quality
Q3C(R9) Risk-Based Approach for Evaluation and Control Strategy of Residual Solvents in Pharmaceuticals Ji Sun Yoo
(Daewoong Pharm)
Q3D(R2) Elemental Impurity Risk Assessment Andrew Teasdale
(ATCMC Solutions Limited)
Q9(R1) Integration of QRM in Quality Management Systems -Quality Management System Applications of Risk-Based Decision-Making Approaches Marion de la Cruz-Kuo
(MSD)
Q2(R2)/Q14 Analytical Procedure Development and Change Management Concepts in ICH Q14 Nina Cauchon
(Amgen)
Q2(R2)/Q14 ICH Q2(R2)/Q14 Training based on Training Materials Yukio Hiyama
(National Institute of Health Sciences)
Q3E EWG ICH Q3E: Guideline for Extractable and Leachables Patricia Parris
(Pfizer)
Multidisciplinary
M7(R2) M7(R2): N-Nitrosamines -Past, Present and Future Andrew Teasdale
(ATCMC Solutions Limited)
M7(R2) ICH M7(R2) - Risk-Based Assessment and Control Strategies for Genotoxic Impurities Using Real-World Case Studies (Including Manufacturing Processes) Kazusei Komatsu
(Shionogi)
M4Q(R2) EWG ICH M4Q(R2) and the Way Forward Lawrence Yu
(FDA)
M14 EWG Introduction to the ICH M14 Guideline (Step 3) Bongkyoo Choi
(GC Biopharma)
M15 EWG Envisioning Global Harmonization of MIDD: Opportunities and Challenges in the Implementation of the New ICH M15 MIDD Guidelines Jiawei Wei
(Novartis)
Daisuke Iwata
(PMDA)
Efficacy
E2C(R2) Mastering PBRER Preparation: Best Practices and Global Regulatory Insights Minkyung Shin
(Selta Square)
E6(R3) ICH E6(R3) – The implementation Rebecca Stanbrook
(Novartis Pharma AG)
E14/S7B Best practice condideration for the in vitro cardiac ion channel and in vivo QT studies (S7B Q&A, Best practice) Joung-Wook Seo
(Korea Institute of Toxicololgy)
Safety
S2(R1) Interpretation of S2(R1) Genotoxicity Data, Decision Criteria, and Regulatory Response Cases Hyun-Kul Lee
(Corestemchemon)
S10 Photosafety Evaluation of Pharmaceuticals since Implementation of ICH S10 Daniel Bauer
(Novartis Pharma AG)